The field of combination products is dynamic and is constantly growing and developing in the world and within Israel as well. This field include products made of a combination of different components (such as device, biologics or and/or drugs). The regulatory requirements in this field are getting more and more complex and raise new standards and challenges, due to the...
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The field of combination products is dynamic and is constantly growing and developing in the world and within Israel as well. This field include products made of a combination of different components (such as device, biologics or and/or drugs). The regulatory requirements in this field are getting more and more complex and raise new standards and challenges, due to the complexity of these products.
Being these combination products, the development pathways to be used may be different and the strategy chosen might lead to a different outcome in terms of product requirements and time to market. The regulatory strategy to be selected is therefore particularly critical for the success of the development of these types of product.
The course is aimed to provide an overview of the current regulatory guidelines in this field. The course provides information about the life cycle of these products and different regulatory approach for biological products, pharmaceuticals and medical devices and focuses on the possible approaches for these type of products.
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